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Sponsored by: |
University of Michigan Cancer Center |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00143884 |
This research project will focus on whether it is safe and effective to rely on donor cells to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell transplant.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma, Low-Grade Lymphoma, Non-Hodgkin's Multiple Myeloma Myelodysplastic Syndromes |
Procedure: Reduced intensity conditioning Procedure: Prophylactic donor leukocyte infusions |
Phase II |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Allogeneic Stem Cell Transplantation Using Low Intensity Conditioning |
Estimated Enrollment: | 30 |
Study Start Date: | March 2000 |
This research project will focus on whether it is safe and effective to rely on donor cells to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell transplant (SCT). For many patients with these conditions, a bone marrow transplant can be the only chance for cure. The standard type of bone marrow transplant involves giving very high-doses of chemotherapy and radiation to kill all the cancer cells followed by an infusion of bone marrow stem cells from a relative who is a bone marrow match. After the transplant the patient takes anti-rejection drugs for many months to prevent the donor’s immune cells from causing a severe reaction called Graft-versus-Host Disease (GVHD), which can even be fatal. However, for some patients with certain types of high-risk cancer even this intense treatment is not effective and the cancer relapses.
Is has been known for many years that some of the bone marrow cells from the donor can kill cancer cells. Recently, it has been discovered that sometimes patients who relapse after a bone marrow SCT can be cured by giving an infusion of donor white blood cells (called a donor leukocyte infusion or DLI). By giving a DLI BEFORE a relapse happens, hopefully relapse can be prevented.
The high doses of chemotherapy and radiation therapy given prior to a standard bone marrow stem cell transplant can make a patient very sick and also increase the chance of getting severe GVHD. In this research study we are going to rely mainly on the donor cells to kill the cancer cells, and patients will receive dosages of chemotherapy that are lower than the usual dosages. It is thought that this low intensity conditioning will make the transplant safer without risking more relapses, however it is not know whether low intensity conditioning is safer than standard conditioning.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patient Inclusion Criteria:
One of the following hematological malignancies:
Chronic myelogenous leukemia
Acute myelogenous leukemia
Acute lymphoblastic leukemia
Myelodyplastic syndromes
Non-Hodgkin’s Lymphoma
Multiple myeloma patients, any age, who meet at least one of the following criteria:
Chronic lymphoblastic leukemia patients
Mantle cell lymphoma
Any eligible disease category, any age, if ineligible for myeloablative conditioning because of organ dysfunction or advanced age (55 years or older). Minimum organ function for patients entered on this protocol defined as:
Low grade lymphoma (small lymphocytic, follicular small cleaved cell, or follicular mixed small cleaved and large cell) must meet the following criteria:
Patient Exclusion Criteria:
Donor Inclusion Criteria:
Donor Exclusion Criteria:
United States, Michigan | |
The University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | John E. Levine, MS MD | The Univeristy of Michigan |
Study ID Numbers: | UMCC 9979 |
Study First Received: | August 31, 2005 |
Last Updated: | April 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00143884 |
Health Authority: | United States: Institutional Review Board |
Myelodysplastic syndromes Immunoproliferative Disorders Precancerous Conditions Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Myelodysplasia Myelodysplastic Syndromes Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Leukemia Lymphatic Diseases Preleukemia Hemorrhagic Disorders Multiple myeloma Bone Marrow Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type |
Immune System Diseases Syndrome Cardiovascular Diseases |